A Study of Biological Effects of a Polyphenol Supplement

Not Applicable

Completed

Brief Summary: A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product "DailyColors™" (DC) on age-related pathways in adults.

The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers.

Based on power calculations a sample size of 20, is sufficient to detect an effect size of 0.46 at a power \> 90%. To account for dropout the investigators will include 26 subjects in total.

Detailed Description: Aims:

The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers.

Hypotheses:

There will be preliminary evidence that the IP has positive clinical effects on biologically relevant pathways related to healthy aging of brain and muscle including blood markers of inflammation, oxidative stress markers, and trophic factors.

Design:

A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product (DailyColors™) on age-related pathways in adults. Participants will receive DailyColors™ or placebo for a week, then one week wash-out, and then placebo/Dailycolors™ for a week, in random order. In addition, participants will be invited to participate in an open-label extension study for 3 months.

Recruitment & Eligibility

Inclusion Criteria

Male or female, (NB Equal number of male and female participants)
Age between 55 and 80
Body Mass Index (BMI) over 25 (since this group is expected to have a some degree of inflammation and other metabolic changes and more likely to respond to the supplement)
Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study.

Exclusion Criteria

Alcohol or drug abuse in past year
Subject has a known allergy to the test material's active or inactive ingredients
Subjects with unstable, life-threatening medical conditions
Use of polyphenol or phytochemical supplements
Use of dietary supplements last month, except from cod liver oil or other vitamin D supplements
Vegetarians and Vegans
Clinically significant abnormal laboratory results at screening
Participation in a clinical research trial within 30 days prior to randomization
Individuals with dementia and/or who are unable to give informed consent
Individuals with unusual high intake of fruit, berries, vegetable and/ or coffee intake, > 5 portions of fruit, berries and/or vegetables per day or > 5 cups of coffee per day
Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Micro crystalline cellulose will be used as the placebo, which will be produced with similar appearance as the active compound visually and regarding smell and taste.
DailyColors™ group	DailyColors™	Capsules of 150 mg of the DailyColors™ blend The investigational product is a capsule containing 150mg of the following phytonutritients: Item Name Percent of Formula Apple Extract 10.0% Pomegranate Extract 10.0% Tomato Powder 2.5% Beet - Spray Dried 2.5% Olive Extract 7.5% Rosemary Extract 7.5% Green Coffee Bean Extract (C.A) 7.5% Kale - Freeze Dried 2.5% Onion Extract 10.0% Ginger Extract 10.0% Grapefruit Extract 2.5% Carrot - Air Dried 2.5% Grape Skin Extract 17.5% Blueberry Extract 2.5% Currant - Freeze Dried 2.5% Elderberry - Freeze Dried 2.5%

Primary Outcome Measures

Name	Time	Method
Blood levels of CD38	3 weeks	Change from baseline in the blood levels of CD38 at 1hour, 2 hours, 24 hours and week 1 and week 3. Blood CD38 is measured using commercially available immunoassays.
Blood levels of NAD+	3 weeks	Change from baseline in the blood levels of NAD+ at 1hour, 2 hours, 24 hours and week 1 and 3. Blood NAD+ is measured using commercially available assay kits.

Secondary Outcome Measures

Name	Time	Method
Blood levels of protein carbonyl	3 weeks	Change from baseline in the blood levels of protein carbonyl at week 1 and week 3, which are measured using commercially available assays.
Blood levels of biomarkers for inflammation	3 weeks	Change from baseline in the blood levels of inflammatory biomarkers, such as IL-6, TNF-α and IL-10, and IL-8 at week 1 and 3. All blood biomarkers are measured using commercially available immunoassays. All biomarkers have the same unit of measure, namely pg/mL.
Blood-based measurement of total antioxidant capacity	3 weeks	Change from baseline in the blood-based total antioxidant capacity at week 1 and 3, which are measured using commercially available assays.
Blood levels of 4-HNE	3 weeks	Change from baseline in the blood levels of 4-HNE at week 1 and week 3, which are measured using commercially available assays.